HealthyPhase 1NCT02238834

Phase 1 Safety, Tolerability and Pharmacokinetics (PK) Study of FP-025 in Healthy Volunteers

A Phase 1 study testing FP-025 in people with Healthy, run by Foresee Pharmaceuticals Co., Ltd. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a randomized, placebo controlled, single and multiple ascending dose study to assess the safety and tolerability and pharmacokinetics of FP-025 in healthy subjects. Note: Dosing in the SAD phase was completed, and the planned MAD portion of the study was not conducted. Read more about this study

Who is it for?: Ages 20 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: FP-025
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteTaiwan
Study dates: Jun 2015to Dec 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Males aged ≥20 and ≤65 years with a BMI ≥18 kg/m2 and ≤30 kg/m2.
A resting pulse ≥50 bpm and ≤100 bpm at the Screening Visit.
A resting systolic blood pressure of ≤140 mmHg and a resting diastolic blood pressure of ≤90 mmHg at the Screening Visit and the Safety Baseline Visit.
Baseline laboratory test values within reference ranges based on the blood and urine samples taken at the Screening Visit. Out of normal ranges values (except for liver parameters) may be accepted by the investigator, if not clinically significant.
The subject is, in the opinion of the investigator, generally healthy based on assessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
Adequate contraception (double-barrier) will be applied during and until 3 months after completion of the study.
Signed Informed Consent prior to any study related procedures.
Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.

Who cannot join

The subject has taken prescription or non-prescription medication, herbal remedies, vitamins or minerals within 2 weeks prior to the first dose of study product (or within 5 half-lives prior to inclusion for any medication ingested, whichever is longer).
The subject has a substance abuse-related disorder or has a significant history of drug or alcohol abuse, or a history of drug abuse or a history of substance abuse deemed significant by the investigator.
The subject should avoid alcohol for at least 5 days before admission into the clinic.
The subject has taken any investigational products within 30 days prior to the first dose of study product.
The subject has a history of severe drug allergy or hypersensitivity or food allergy.
The subject has a history or presence of any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (in particular diabetes or pre-diabetes), haematological, dermatological, venereal, neurological, chronic infectious or psychiatric disease or other major disorder.

Show all 24Show fewer

The subject has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, which has not been in remission for at least 5 years prior to the first dose of study product.
The subject has a history of abdominal surgery (excluding laparoscopic cholecystectomy or uncomplicated appendectomy) or thoracic or non-peripheral vascular surgery within 6 months prior to the first dose of study product.
The subject has any concurrent illness that may affect the particular target or absorption, distribution, and elimination of the study product.
The subject has had a clinically significant illness within 4 weeks prior to the first dose of study product.
The subject has had surgery or trauma with significant blood loss within the last 3 months prior to the first dose of study product.
The subject has donated blood more than 250 mL within 2 months prior to the first dose of study product.
The subject has tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV).
The subject is a current smoker or uses other nicotine containing products. Ex-smokers must have ceased smoking at least 6 months prior to the first dose of study product (+ <10 pack years).
The subject has tested positive at the Screening Visit and at the Safety Baseline Visit for drugs of abuse (amphetamine, cannabinoid, cocaine, morphine, and phencyclidine).
The subject's corrected QT interval (QTc) (Bazett's or Fridericia's correction) is >450 ms as read on the printout of the ECG produced by the ECG equipment and evaluated by the investigator at the Screening Visit and at the Safety Baseline Visit. An out-of-range or abnormal ECG may be repeated. In total, 3 ECGs should be recorded consecutively and the investigator must evaluate the triplicate ECG. If the subject's QTc is >450 ms on at least 2 ECGs, the subject must be excluded.
The subject exercises extensively (e.g. marathon, triathlon or other similar high energetic sports). In general, subjects should refrain from sporting for at least 4 days before participation to the study.
The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
A history of psychiatric diseases, i.e depression and/or anxiety related illness.
Serum creatinine, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) above the upper limit of normal (ULN) and deemed clinically significant by the investigator at screening and at the Safety Baseline Visit.
Hemoglobin, white blood cells (WBC) or platelet count below the lower limit of normal (LLN) and deemed clinically significant by the investigator at screening and at the Safety Baseline Visit.
Other laboratory results which are clinically significant abnormal at screening and at the Safety Baseline Visit.
Legal incapacity or limited legal capacity at screening and at the Safety Baseline Visit.
Employees of the investigator or study centre, as well as first grade family members of the employees or the investigator.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Taipei Veterans General Hospital
Taipei, 11217

Other trials in Taiwan

About this study

Official title: A Randomized, Double-blind, Placebo Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of FP-025, an MMP-12 Inhibitor, in Healthy Male Subjects

This is a randomized, placebo controlled, single and multiple ascending dose study to assess the safety and tolerability and pharmacokinetics of FP-025 in healthy subjects.

Note: Dosing in the SAD phase was completed, and the planned MAD portion of the study was not conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No. FP02C-17-001).

Read the detailed description

In the SAD part of the study the investigational drug will be administered once in a dose escalation manner starting from 200 mg in Cohort 1 to 2000 mg in Cohort 6. The study drug will be orally taken as capsules. In the MAD part of the study the investigational drug will be administrated twice daily for 5 days depending on the half-life of FP-025, as determined in the SAD part of the study. Study subjects will be randomized in a 1:3 ratio to either placebo or FP-025 in every cohort of the SAD and MAD part of the study.

Conditions: Healthy
Being tested: FP-025, Placebo
Keywords: Phase I, Safety and tolerability, Pharmacokinetic, Randomized, Double Blind, Placebo-Controlled, Single- & Multiple Dose Escalation, FP-025, MMP-12 inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FP-025Drug
Subjects will receive single doses of 200 to up to 800 mg of FP-025 (API-in-capsule) in a dose escalation format (cohorts 1-3). Subjects will receive single doses of 50 to up to 450 mg of FP-025 (ASD-in-capsule) in a dose escalation format (cohorts 4-8).
PlaceboDrug
Subjects will receive single doses of FP-025 matching placebo (capsule) in a dose escalation format.
FP-025Drug
Subjects will receive doses of FP-025 (capsule) twice daily for 5 days.
PlaceboDrug
Subjects will receive FP-025 matching placebo (capsule) twice daily for 5 days

Study groups in NCT02238834
Study group	Role	What they receive
SAD Cohorts 1-8 Experimental Arm	Experimental	Not described Receives: Drug: FP-025
SAD Cohorts 1-8 Placebo Arm	Placebo comparator	Not described Receives: Drug: Placebo
MAD Cohorts 1 through 4 Experimental Arm	Experimental	Note: The planned MAD portion of the study was not conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No. FP02C-17-001). Receives: Drug: FP-025
MAD Cohorts 1 through 4 Placebo Arm	Placebo comparator	Note: The planned MAD portion of the study was not conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No. FP02C-17-001). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Single ascending dose (SAD): Safety and tolerability of FP-025
Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, and ECG monitoring
Measured: 9 days
Multiple ascending dose (MAD): Safety and tolerability of FP-025
Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, and ECG monitoring
Measured: 13 days

Secondary outcomes (2)

Single ascending dose (SAD): Pharmacokinetics of FP-025
Plasma concentrations of FP-025
Measured: 2 days
Multiple ascending dose (MAD): Pharmacokinetics of FP-025
Plasma concentrations of FP-025
Measured: 6 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Dec 2018

First posted12 Sep 2014 (estimated)
Study startJun 2015
Primary completionDec 2018
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02238834
Sponsor's protocol ID: FP02C-14-001
Status last verified: Aug 2022
First submitted: 5 Sep 2014
Last updated: 8 Aug 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Abd-Elaziz K, Voors-Pette C, Wang KL, Pan S, Lee Y, Mao J, Li Y, Chien B, Lau D, Diamant Z. First-in-Man Safety, Tolerability, and Pharmacokinetics of a Novel and Highly Selective Inhibitor of Matrix Metalloproteinase-12, FP-025: Results from Two Randomized Studies in Healthy Subjects. Clin Drug Investig. 2021 Jan;41(1):65-76. doi: 10.1007/s40261-020-00981-9. Epub 2020 Dec 17.
PubMed 33331980

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of FP-025, an MMP-12 Inhibitor, in Healthy Male Subjects
ClinicalTrials.gov ID: NCT02238834
Acronym / sponsor ID: FP02C-14-001
Conditions: Healthy
Keywords: Phase I, Safety and tolerability, Pharmacokinetic, Randomized, Double Blind, Placebo-Controlled, Single- & Multiple Dose Escalation, FP-025
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (estimated)
Lead sponsor: Foresee Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: QPS-Qualitix
Study start: Jun 2015 (actual)
Primary completion: Dec 2018 (actual)
Study completion: Dec 2018 (actual)
First posted: 12 Sep 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a randomized, placebo controlled, single and multiple ascending dose study to assess the safety and tolerability and pharmacokinetics of FP-025 in healthy subjects.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
SAD Cohorts 1-8 Experimental Arm	Experimental	Drug: FP-025
SAD Cohorts 1-8 Placebo Arm	Placebo comparator	Drug: Placebo
MAD Cohorts 1 through 4 Experimental Arm	Experimental	Drug: FP-025Note: The planned MAD portion of the study was not conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No. FP02C-17-001).
MAD Cohorts 1 through 4 Placebo Arm	Placebo comparator	Drug: PlaceboNote: The planned MAD portion of the study was not conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No. FP02C-17-001).

Who may qualify

Ages: 20 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Males aged ≥20 and ≤65 years with a BMI ≥18 kg/m2 and ≤30 kg/m2.
A resting pulse ≥50 bpm and ≤100 bpm at the Screening Visit.
A resting systolic blood pressure of ≤140 mmHg and a resting diastolic blood pressure of ≤90 mmHg at the Screening Visit and the Safety Baseline Visit.
Baseline laboratory test values within reference ranges based on the blood and urine samples taken at the Screening Visit. Out of normal ranges values (except for liver parameters) may be accepted by the investigator, if not clinically significant.
The subject is, in the opinion of the investigator, generally healthy based on assessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.

Key exclusion criteria (24 listed)

The subject has taken prescription or non-prescription medication, herbal remedies, vitamins or minerals within 2 weeks prior to the first dose of study product (or within 5 half-lives prior to inclusion for any medication ingested, whichever is longer).
The subject has a substance abuse-related disorder or has a significant history of drug or alcohol abuse, or a history of drug abuse or a history of substance abuse deemed significant by the investigator.
The subject should avoid alcohol for at least 5 days before admission into the clinic.
The subject has taken any investigational products within 30 days prior to the first dose of study product.
The subject has a history of severe drug allergy or hypersensitivity or food allergy.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FP-025Subjects will receive single doses of 200 to up to 800 mg of FP-025 (API-in-capsule) in a dose escalation format (cohorts 1-3). Subjects will receive single doses of 50 to up to 450 mg of FP-025 (ASD-in-capsule) in a dose escalation format (cohorts 4-8).	Drug	SAD Cohorts 1-8 Experimental Arm
PlaceboSubjects will receive single doses of FP-025 matching placebo (capsule) in a dose escalation format.	Drug	SAD Cohorts 1-8 Placebo Arm
FP-025Subjects will receive doses of FP-025 (capsule) twice daily for 5 days.	Drug	MAD Cohorts 1 through 4 Experimental Arm
PlaceboSubjects will receive FP-025 matching placebo (capsule) twice daily for 5 days	Drug	MAD Cohorts 1 through 4 Placebo Arm

Primary outcome

Single ascending dose (SAD): Safety and tolerability of FP-025
Time frame: 9 days
Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, and ECG monitoring
Multiple ascending dose (MAD): Safety and tolerability of FP-025
Time frame: 13 days
Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, and ECG monitoring

2 secondary outcomes

Single ascending dose (SAD): Pharmacokinetics of FP-025
Time frame: 2 days
Multiple ascending dose (MAD): Pharmacokinetics of FP-025
Time frame: 6 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
Derived from this study: PubMed 33331980Abd-Elaziz K, Voors-Pette C, Wang KL, Pan S, Lee Y, Mao J, Li Y, Chien B, Lau D, Diamant Z. First-in-Man Safety, Tolerability, and Pharmacokinetics of a Novel and Highly Selective Inhibitor of Matrix Metalloproteinase-12, FP-025: Results from Two Randomized Studies in Healthy Subjects. Clin Drug Investig. 2021 Jan;41(1):65-76. doi: 10.1007/s40261-020-00981-9. Epub 2020 Dec 17.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FP-025 in people with Healthy, run by Foresee Pharmaceuticals Co., Ltd. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Single ascending dose (SAD): Safety and tolerability of FP-025 (time frame: 9 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02238834, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.